Transplantation of Human Organs and Tissues Act (THOTA), 1994

GS II-Regulatory

The Transplantation of Human Organs and Tissues Act (THOTA), 1994 governs organ and tissue transplantation in India, outlining legal provisions for donation, procurement, and penalties for violations.

Key Provisions of THOTA, 1994

• Regulates organ donation and transplantation after death.
• Establishes guidelines for healthcare providers and hospitals involved in transplantation.
• Prescribes penalties for illegal activities, including organ trade.

Organ Donation and Transplantation

Eligible Donors

1. Deceased Donors: Organs from brain-dead individuals can be donated by their relatives.
2. Living Donors: Close relatives such as parents, siblings, children, spouses, grandparents, and grandchildren can donate organs.

Donations from Distant Relatives and Foreign Nationals

• Distant relatives, in-laws, or long-time friends can donate after thorough verification to prevent commercial transactions.
• If the donor or recipient is a foreign national, documents such as family trees and photographs proving their relationship must be submitted.

Unrelated Donations

• If the donor is unrelated, strong documentary and photographic evidence is required to establish a long-term relationship.
• An external committee reviews such cases to prevent illegal dealings.

Penalties for Violations

• Offering or receiving payment for organs is strictly prohibited.
• Involvement in illegal organ trade, including advertising, negotiation, or preparing false documents, can result in:
  • Up to 10 years of imprisonment.
  • A fine of up to ₹1 crore.

Formation of NOTTO

• The National Organ and Tissue Transplant Organization (NOTTO) was established under the Transplantation of Human Organs (Amendment) Act, 2011.
• It functions as the apex body for organ procurement, distribution, and transplantation coordination across India.

THOT Rules, 2014

The THOT Rules, 2014 provide specific guidelines for organ transplantation approval, living donor applications, and committee responsibilities.

Authorization Committee (Rule 7)

• Approves transplants involving non-related donors to prevent financial transactions.
• Ensures ethical compliance by interviewing applicants and verifying their documents.
• If a recipient is critically ill, hospitals can expedite evaluation within a week.

Living Donor Transplantation (Rule 10 & Rule 21)

• Joint applications by the donor and recipient are required for approval.
• The committee personally interviews applicants to confirm voluntary donation.

Role of the Authorization Committee

The Authorization Committee is responsible for approving transplants involving donors and recipients who are not close relatives.

Composition and Powers

• State Governments and Union Territories are required to form one or more Authorization Committees.
• The committee verifies documents, donor-recipient relationships, and ensures no commercial motive behind donations.
• Under Section 9(5), the committee must conduct a detailed inquiry before approving a transplant.

Role of Parliament

• Under Section 24, the Centre can frame rules to regulate various aspects of organ transplantation, including:
  • Procedures for authorizing organ donation before death.
  • Certification of brain-stem death.
  • Preservation and transport of organs.

Recent High Court Rulings on Organ Transplantation

1. Formation of Authorization Committees
   • The High Court reaffirmed the need for state governments and UTs to establish Authorization Committees.
   • Emphasized the importance of strict regulations to prevent illegal organ trade.
2. Timelines for Living Donor Applications
   • The entire application process must not exceed 10 days from the submission date.
   • Document verification should be completed within 14 days.
   • Any additional requirements must be communicated within the prescribed timeline.
3. Interviews and Family Meetings
   • Interviews must be scheduled within two weeks of receiving the application.
   • The decision-making process should ideally conclude within six to eight weeks.
4. Recommendations to the Government
   • The High Court directed the Ministry of Health and Family Welfare to establish clear timelines and procedures for organ donation applications.
   • Stakeholder consultations were suggested for improving the implementation of transplantation laws.

The THOTA, 1994 and THOT Rules, 2014 establish a comprehensive legal framework for organ donation and transplantation in India. NOTTO and Authorization Committees play a crucial role in ensuring ethical and legal compliance, while strict penalties deter illegal organ trade. Recent High Court rulings have emphasized timely approvals, transparency, and accountability in the transplantation process.